Delivery System with Inline Sheath

ABSTRACT

Systems and methods for delivering and implanting heart valves are disclosed. The delivery systems can include an integrated introducer. The integrated introducer can include a sheath having an inner diameter that is smaller than the outer diameter of a delivery capsule of the delivery system and an outer diameter that is approximately equal to the outer diameter of the delivery capsule. The integrated introducer can include a hub having a hemostatic seal. The hub can have a locking mechanism configured to fix the integrated introducer in place on the delivery system.

BACKGROUND Field

The present disclosure relates to heart valve delivery systems andmethods of delivering and implanting heart valves. More specifically,the present disclosure relates to delivery systems with an integratedintroducer. The integrated introducer can include a hub having ahemostatic seal.

Background

Minimally invasive approaches have been developed to facilitatecatheter-based implantation of valve prostheses on the beating heart,intending to obviate the need for the use of classical sternotomy andcardiopulmonary bypass. For example, U.S. Pat. No. 8,016,877 to Seguinet al. illustrates a technique and a device for replacing a deficientheart valve by percutaneous route. An expandable prosthetic valve can becompressed about a catheter, inserted inside a lumen within the body,such as the femoral artery, and delivered to a desired location in theheart. Additionally, U.S. Pat. No. 7,914,569 to Nguyen et al. disclosesadvancing a catheter containing a prosthesis in a retrograde mannerthrough the femoral artery and into the descending aorta, over theaortic arch, through the ascending aorta and inside the defective aorticvalve. This procedure can be assisted by fluoroscopic guidance. Once theposition of the catheter containing the prosthesis is confirmed, asheath containing the prosthesis can be moved proximally, allowing thevalve prosthesis to self-expand.

With regard to the structure of the heart valve prosthesis itself, U.S.Pat. No. 7,914,569 to Nguyen et al. describes an example prosthesis forpercutaneous transluminal delivery. The heart valve prosthesis can havea self-expanding multi-level frame that supports a valve body with askirt and plurality of leaflets. The frame can be contracted duringpercutaneous transluminal delivery and expanded to an hourglass shapeupon deployment within the native heart valve.

Other techniques for delivering prosthetic heart valves via a catheterinclude a transapical approach for aortic valve replacement, typicallyinvolving the use of an introducer port, i.e., a large-bore overtube, ofa trocar. A crimped, framed valve prosthesis reversibly coupled to adelivery catheter can be transcatheterally advanced toward the nativevalve, where it can be either forcefully deployed using a ballooncatheter, or, alternatively, passively deployed using a self-expandablesystem.

Typical introducer systems contain an access lumen for introduction oftranscatheter medical devices, a hub for connection to syringes andother peripheral devices, and a hemostatic valve to prevent blood lossfrom the lumen of the introducer sheath. The profile, or outer diameter,of the introducer can be a limiting factor in whether certaintranscatheter medical devices can be introduced into a patient becausesufficient vessel size is necessary to accommodate the introducersheath. In order to extend the availability of transcatheter devices topatients with smaller vessel sizes, an introducer with a smaller profileis desired.

BRIEF SUMMARY

The present disclosure relates to delivery systems for medical devices,for example, prosthetic heart valves. The delivery systems disclosedherein can include a handle, a delivery capsule, an inner lumenconnecting the handle and the delivery capsule, and an integratedintroducer. In certain embodiments, the integrated introducer can beslidably disposed about, and move freely along, the inner lumen.Generally, the inner diameter of the integrated introducer is smallerthan the maximum outer diameter of the delivery system, and the outerdiameter of the integrated introducer is approximately equal to theouter maximum outer diameter of the delivery system.

In certain embodiments, the integrated introducer can include a sheathwhere the inner diameter of the sheath is smaller than the outerdiameter of a delivery capsule of the delivery system and the outerdiameter of the sheath is approximately equal to the outer diameter ofthe delivery capsule. This relationship can provide a smooth transitionbetween the delivery capsule and the sheath of the integratedintroducer. In certain embodiments, the outer diameter of the sheath canbe larger or smaller than the outer diameter of the delivery capsule.The integrated introducer can reduce the overall profile of the combineddelivery system and introducer in comparison to traditional, separateintroducer and delivery systems. This can eliminate the need for aseparate introducer component to be used with the delivery system.Minimizing the access profile of the delivery system can increase thepotential patient population and reduce trauma associated withtransluminal delivery of medical devices.

In certain embodiments, the integrated introducer can include a hubhaving a hemostatic valve located within an interior space of the hub.The hemostatic valve can fit against a retention element to provide atight seal. The hemostatic seal can maximize leak pressure whilereducing tracking force. In certain embodiments, the hub can include alocking element configured to lock the integrated introducer at alocation along the inner lumen of the delivery system.

Integrated introducers are also disclosed. In certain embodiments, theintegrated introducer can include a sheath and a hub having a hemostaticvalve located within an interior space of the hub. In certainembodiments, the sheath can include a rigid ring located at a distal endof the sheath. The rigid ring can prevent the integrated introducer fromriding up over the delivery capsule of the delivery system. In certainembodiments, the inner diameter of the sheath can be smaller than anouter diameter of the delivery capsule and the outer diameter of thesheath can be approximately equal to an outer diameter of the deliverycapsule. In certain embodiments, the outer diameter of the sheath can belarger or smaller than the outer diameter of the delivery capsule.

Methods of delivering a medical device are also disclosed. A deliverysystem having an integrated introducer such as those described hereincan be inserted into a body lumen, where the delivery capsule contactsthe sheath (or rigid ring tip) of the integrated introducer in aninsertion configuration. The delivery capsule can be advanced distallysuch that it breaks contact with the integrated introducer. The deliverycapsule can be maneuvered through the vasculature to a deploymentlocation, and the medical device can be deployed at the deploymentlocation. The delivery system can then be removed from the body lumen.

In certain embodiments, the method of delivering the medical device caninclude disconnecting the integrated introducer from the handle of thedelivery system. In certain embodiments, a hub connected to the sheathcan include a locking element, and the method can include sliding theintegrated introducer along the inner lumen or stability member of thedelivery system and locking the integrated introducer in place byactivating the locking element to grip the inner lumen or stabilitymember.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, which are incorporate herein, form part of thespecification and illustrate embodiments of prosthetic valves havingdirectionally distinguishable markers. Together with the description,the figures further to serve to explain the principals of and allow forthe making and using of the prosthetic valves described herein. Thesefigures are intended to be illustrative, not limiting. Although thedisclosure is generally described in the context of these embodiments,it should be understood that it is not intended to limit the scope ofthe disclosure to these particular embodiments. In the drawings, likereference number indicate identical or functionally similar elements.

FIG. 1A illustrates a delivery system including an integratedintroducer, according to an embodiment.

FIG. 1B illustrates a handle and inline sheath introducer of a deliverysystem, according to an embodiment.

FIG. 2 illustrates an inline sheath introducer, according to anembodiment.

FIG. 3A illustrates a hub, according to an embodiment.

FIG. 3B illustrates an interior view of a hub, according to anembodiment.

DETAILED DESCRIPTION

While the disclosure refers to illustrative embodiments for particularapplications, it should be understood that the disclosure is not limitedthereto. Modifications can be made to the embodiments described hereinwithout departing from the spirit and scope of the present disclosure.Those skilled in the art with access to this disclosure will recognizeadditional modifications, applications, and embodiments within the scopeof this disclosure and additional fields in which the disclosed examplescould be applied. Therefore, the following detailed description is notmeant to be limiting.

Further, it is understood that the devices and methods described belowcan be implemented in many different embodiments of hardware. Any actualhardware described is not meant to be limiting. The operation andbehavior of the device, systems, and methods presented are describedwith the understanding that modifications and variations of theembodiments are possible given the level of detail presented.

References to “one embodiment,” “an embodiment,” “in certainembodiments,” etc., indicate that the embodiment described may include aparticular feature, structure, or characteristic, but every embodimentmay not necessarily include the particular feature, structure, orcharacteristic. Moreover, such phrases are not necessarily referring tothe same embodiment. Further, when a particular feature, structure, orcharacteristic is described in connection with an embodiment, it issubmitted that it is within the knowledge of one skilled in the art toaffect such feature, structure, or characteristic in connection withother embodiments whether or not explicitly described.

FIG. 1A illustrates delivery system 100, according to an embodiment.Delivery system 100 can include distal tip 102, delivery capsule 104,and inner lumen 106. In certain embodiments, delivery system 100 caninclude integrated introducer 110, which can be configured about innerlumen 106. In certain embodiments, integrated introducer 110 can includeinline sheath 112, tip ring 114, and hub 120. In certain embodiments,delivery system 100 can include stability member 116. In certainembodiments, delivery system 100 can include handle 130. The componentsof delivery system 100 can be made of any suitable materials. Forexample, the components can be biocompatible plastics, metals and/orcomposite materials.

In certain embodiments, inner lumen 106 can connect handle 130 anddelivery capsule 104. By manipulating a control mechanism on handle 130,inner lumen 106 can be advanced distally and retracted proximally. This,in turn, can advance and retract delivery capsule 104 and distal tip102. In certain embodiments, delivery capsule 104 can house a prostheticheart valve (not shown). The prosthetic heart valve can be configured tobe collapsible and expandable such that it can be compressed to fitwithin delivery capsule 104 during delivery and expanded, eithermanually or by self-expansion, upon deployment. In certain embodiments,distal tip 102 can be tapered to facilitate guiding the delivery systemthrough the vasculature while preventing trauma.

FIG. 1B illustrates integrated introducer 110 and handle 130 of deliverysystem 100, according to an embodiment. In certain embodiments,integrated introducer 110 can include inline sheath 112, tip ring 114,stability member 116, and hub 120. In certain embodiments, inline sheath112 and/or stability member 116 can be detached and reattached with thehandle 130.

In certain embodiments, inline sheath 112 can be slidably disposed aboutstability member 116, which can extend from handle 130 to deliverycapsule 104 (shown in FIG. 1A). In certain embodiments, the materials ofstability member 116 and inline sheath 112 can reduce friction betweenthe components, which can allow inline sheath 112 to slide easily alongstability member 116. In certain embodiments, inline sheath 112 caninclude a liner or lubricant to reduce friction with stability member116. In certain embodiments, stability member 116 can be made of amaterial that is more rigid than inline sheath 112. For example, incertain embodiments, stability member 116 can be a rigid plastic andinline sheath 112 can be a flexible plastic. In certain embodiments,stability member 116 can be disconnected from handle 130 and reconnectedto handle 130. In certain embodiments, an outer diameter of stabilitymember 116 can be approximately equal to an outer diameter of deliverycapsule 104. In certain embodiments, an outer diameter of stabilitymember 116 can be larger or smaller than an outer diameter of deliverycapsule 104. In certain embodiments, stability member 116 and inlinesheath 112 can be a single component, which can include any or all ofthe features of stability member 116 and inline sheath 112 describedherein.

In certain embodiments, inline sheath 112 can include tip ring 114. Incertain embodiments, tip ring 114 can be located at a distal end ofinline sheath 112 and configured to mate with delivery capsule 104. Incertain embodiments, a locking fit can be formed between tip ring 114and delivery capsule 104, for example, by means of a “hex” fit between adistal end of tip ring 114 and a proximal end of delivery capsule 104.This can facilitate transmitting torque from inline sheath 112 todelivery capsule 104. In certain embodiments, tip ring 114 can be madeof a rigid material. This can prevent inline sheath 112 from expandingand moving over delivery capsule 104 during delivery, which can causevascular complications. Tip ring 114 is explained in further detailbelow with reference to FIG. 2.

In certain embodiments, handle 130 can include proximal portion 132 anddistal portion 134. In certain embodiments, handle 130 can include oneor more buttons 136. In certain embodiments, buttons 136 can bemanipulated to advance and/or retract parts of delivery system 100, forexample, inner lumen 106 (shown in FIG. 1A). It is understood thatbuttons 136 could be other actuation mechanisms, such as knobs,switches, thumbwheels, etc. In certain embodiments, portions of handle130 can move relative to each other, for example, by sliding, twisting,or rotating. In certain embodiments, handle 130 can include grippingfeatures, for example, notches or grooves on the surface of handle 130.

In certain embodiments, handle 130 can include one or more ports 138.Ports 138 can be used as flush ports, to introduce fluids into deliverysystem 100, or connect peripheral devices to delivery system 100, forexample.

FIG. 2 illustrates integrated introducer 110, according to anembodiment. Integrated introducer 110 can include inline sheath 112, tipring 114, and hub 120. In certain embodiments, tip ring 114 can belocated at a distal end of inline sheath 112 and hub 120 can be locatedat or near a proximal end of inline sheath 112.

Inline sheath 112 can be made of any suitable material, for example, butnot limited to, biocompatible plastic. In certain embodiments, inlinesheath 112 can include flexible and rigid portions. For example, aproximal portion of inline sheath 112 can be rigid and a distal portionof inline sheath can be flexible. In certain embodiments, inline sheath112 can be made of a coil reinforced shaft, for example, having abiocompatible polymer jacket. In certain embodiments, the coilreinforcing element can be a different polymer than the jacket, or ametallic element. In certain embodiments, inline sheath 112 can be madeof a braided shaft. In certain embodiments, inline sheath 112 caninclude a welded coil end to prevent flaring. In certain embodiments,inline sheath 112 can be configured as described in U.S. Publication No.2011/0208296, which is incorporated by reference herein in its entirety.In certain embodiments, inline sheath 112 can be coated with a lowfriction polymer (e.g., parylene) or a lubricant (e.g., silicone fluid)to minimize the force needed to slide along inner lumen 106 and/orstability member 116.

In certain embodiments, inline sheath 112 can be an expandable sheath.For example, inline sheath 112 can incorporate features described inU.S. patent application Ser. No. 13/791,110, which is incorporated byreference herein in its entirety. In certain embodiments, inline sheath112 can have a composite design, capable of expanding upon engagementwith the capsule of the delivery system. For example, inline sheath 112can be a slotted tube made of nitinol, which can expand to fit over thecapsule. In certain embodiments, expandable inline sheath 112 caninclude a hemostatic seal using a funnel and valve design. The abilityof inline sheath 112 to expand can allow the user to leave integratedintroducer 110 in the body as a standalone introducer after detaching itfrom the handle, or allow the user to remove integrated introducer 110and use a standard introducer.

In certain embodiments, inline sheath 112 can be steerable. For example,the delivery system can include wires (not shown) that run generallyparallel to the longitudinal axis of integrated introducer 110. Incertain embodiments, the wires can be pre-shaped, and in certainembodiments, the wires can be operated by a control mechanism. The wirescan be controlled, for example, by a mechanism in the handle or in hub120. Manipulating the wires can cause inline sheath 112 to bend,allowing it to be steered through the vasculature.

In certain embodiments, inline sheath 112 can include tip ring 114. Tipring 114 can prevent flaring of inline sheath 112 so that inline sheath112 cannot slide over the delivery capsule of the delivery system. Incertain embodiments, tip ring 114 can mate with the delivery capsule,for example, by friction fit or via an element on each component, forexample complementary snap-fit components. In certain embodiments, tipring 114 can be made of a rigid material, for example, a plastic ormetal band. In certain embodiments, tip ring 114 can be made of solidmetal and welded to inline sheath 112. In certain embodiments, tip ring114 can be a high durometer polymer or composite material. In certainembodiments, tip ring 114 can be made of multiple materials, forexample, a soft polymer and a rigid metal. In certain embodiments, tipring 114 can be a radiopaque material. This can facilitate locating tipring 114 using medical imaging during delivery of a medical device.

FIG. 3A illustrates hub 120, according to an embodiment. Hub 120 can bemade of any suitable material, for example, rubber or plastic. Incertain embodiments, hub 120 can be made from a molded material. Incertain embodiments, exterior surface 122 of hub 120 can have ridges121, which can facilitate gripping hub 120. In certain embodiments,other gripping mechanisms, for example, a textured exterior surface 122can be included on hub 120.

In certain embodiments, hub 120 can include one or more suture hole 123.In certain embodiments, one or more sutures can be threaded throughand/or tied about suture hole 123. The sutures can also be affixed tothe patient, which can attach hub 120 to the patient and maintain theposition of hub 120 relative to the patient.

In certain embodiments, hub 120 can include cavity 125. In certainembodiments, cavity 125 can extend entirely through hub 120 from adistal end to a proximal end. As shown, for example in FIG. 3B, cavity125 can provide an entry point for inner lumen 106 and inline sheath 112into hub 120. In certain embodiments, inline sheath 112 can be attachedto hub 120.

In certain embodiments, hub 120 can include valve 128. In certainembodiments, valve 128 can be connected to inner lumen 106, inlinesheath 112, and/or stability member 116. In certain embodiments, valve128 can be a one-way flush valve. In certain embodiments, valve 128 canbe a stop-cock (e.g., a three-way stop-cock valve) with a tube connectedto hub 120. In certain embodiments, valve 128 can facilitate attachmentof peripheral devices to hub 120. In certain embodiments, fluid, dye,etc., can be introduced into the delivery system, for example into innerlumen 106, inline sheath 112, and/or stability member 116 via valve 128.

FIG. 3B illustrates an interior view of hub 120, according to anembodiment. In certain embodiments, hub 120 can include suture hole 123and valve 128. In certain embodiments, inline sheath 112 can extendwithin an interior space 124 of hub 120. In certain embodiments, innerlumen 106 can extend within interior space 124 of hub 120.

In certain embodiments, hemostatic valve 126 can be located withininterior space 124 of hub 120. Hemostatic valve 126 can be made of anysuitable material, for example rubber, silicone, or plastic. In certainembodiments, hemostatic valve 126 can have a coating, for example, awaterproof coating. In certain embodiments, hemostatic valve 126 can bean “o-ring” type valve. In certain embodiments, hemostatic valve 126 canbe other known types of valves. In certain embodiments, retentionelement 127 can be in contact with hemostatic valve 126. Retentionelement 127 can facilitate hemostatic valve 126 in creating a seal.

In certain embodiments, connector 129 can connect hub 120 with thehandle of the delivery system (not shown). In certain embodiments, innerlumen 106 can extend through connector 129 to connect with the handle.

In certain embodiments, hub 120 can be a locking hub, which can maintainits position on the delivery system. In certain embodiments, hub 120 caninclude a locking actuator (button, switch, wheel, etc.), which can beactivated to lock hub 120 to inner lumen 106 or the stability member(not shown). In certain embodiments, the locking actuator can be coupledto exterior surface 122 of hub 120. In certain embodiments, activatingthe locking actuator can move a locking element within interior space124 of hub 120, which can create a frictional interaction between thelocking element and the delivery system. The frictional interaction canprevent hub 120, and thereby integrated introducer 110, from movingproximally and distally along, or rotating about, the delivery system.In certain embodiments, activating the locking actuator can engagetooth-like components to lock hub 120 in place along inner lumen 106 orstability member 116.

Methods of delivering a medical device are also disclosed. In certainembodiments, the medical device can be a heart valve prosthesis that isdelivery through the vasculature. In certain embodiments, a deliverysystem having an integrated introducer such as those described hereincan be used to deliver delivery the medical device. In certainembodiments, the integrated introducer can include a sheath having anouter diameter that is approximately equal to the outer diameter of adelivery capsule, which can reduce the overall diameter of the deliverysystem.

In certain embodiments, the delivery system can be inserted into a bodylumen. In certain embodiments, the delivery system can have an insertionconfiguration where the delivery capsule contacts the sheath (or rigidring tip) of the integrated introducer. The rigid ring tip can allow thesheath to fit against the delivery capsule but prevent the sheath fromriding up over the delivery capsule of the delivery system. In certainembodiments, the ring tip can be made of a radiopaque material so thatit can be located using medical imaging during the delivery procedure.In certain embodiments, the delivery system can be advanced distallysuch that contact between the delivery capsule and the integratedintroducer is broken.

In certain embodiments, the integrated introducer can be disconnectedfrom the handle. In certain embodiments, the integrated introducer canslide along the inner lumen of the delivery system or along a stabilitymember. In certain embodiments, the integrated introducer can be lockedin place by activating a locking element, for example, on a hub of theintegrated introducer. In certain embodiments, the delivery capsule canbe maneuvered through the vasculature to a deployment location, and themedical device can be deployed at the deployment location. In certainembodiments, a steering mechanism can control wires to maneuver thedelivery system. The delivery system can be removed from the body lumenafter deploying the medical device. In certain embodiments, deliverymethods can be used such as those described in U.S. Publication No.2011/0251683, which is incorporated by reference herein in its entirety.

The foregoing description has been presented for purposes ofillustration and description. It is not intended to be exhaustive or tolimit the precise embodiments disclosed. Other modifications andvariations may be possible in light of the above teachings.

The embodiments and examples were chosen and described in order to bestexplain the principles of the embodiments and their practicalapplication, and to thereby enable others skilled in the art to bestutilize the various embodiments with modifications as are suited to theparticular use contemplated. By applying knowledge within the skill ofthe art, others can readily modify and/or adapt for various applicationssuch specific embodiments, without undue experimentation, withoutdeparting from the general concept. Therefore, such adaptations andmodifications are intended to be within the meaning and range ofequivalents of the disclosed embodiments, based on the teaching andguidance presented herein.

1-22. (canceled)
 23. A delivery system for a medical device comprising:a delivery capsule configured to house the medical device in acompressed delivery state, the delivery capsule comprising a proximalend and a maximum outer diameter; an elongate member extending from theproximal end of the delivery capsule; and an introducer sheath slidablydisposed about the elongate member, the introducer sheath comprising arigid distal end having an inner diameter smaller than the maximum outerdiameter of the delivery capsule, wherein the rigid distal end of theintroducer sheath cannot slide over the maximum outer diameter of thedelivery capsule.
 24. The delivery system of claim 23, wherein an outerdiameter of the introducer sheath is approximately equal to or less thanthe maximum outer diameter of the delivery capsule.
 25. The deliverysystem of claim 23, wherein the rigid distal end of the introducersheath is configured to mate with the proximal end of the deliverycapsule.
 26. The delivery system of claim 23, wherein the rigid distalend of the introducer sheath comprises a radiopaque material.
 27. Thedelivery system of claim 23, wherein the proximal end of the deliverycapsule contacts the rigid distal end of the introducer sheath in aninsertion configuration.
 28. The delivery system of claim 23, whereinthe delivery capsule is located distally from the rigid distal end ofthe introducer sheath in a delivery configuration.
 29. The deliverysystem of claim 23, further comprising a tubular stability memberlocated between the elongate member and the introducer sheath.
 30. Thedelivery system of claim 29, wherein the introducer sheath is slidablydisposed about the tubular stability member.
 31. The delivery system ofclaim 23, wherein the introducer sheath is steerable.
 32. The deliverysystem of claim 23, further comprising a locking element configured tolock the introducer sheath at a location along the elongate member. 33.A delivery system for a medical device comprising: a delivery capsuleconfigured to house the medical device in a compressed delivery state,the delivery capsule comprising a proximal end having an outer diameter;an elongate member extending from the proximal end of the deliverycapsule; and an introducer sheath slidably disposed about the elongatemember, the introducer sheath comprising a rigid distal end having aninner diameter smaller than the outer diameter of the proximal end ofthe delivery capsule, wherein the rigid distal end of the introducersheath cannot slide over the proximal end of the delivery capsule.